Rocío Villamil

• Leading Regional Regulatory Strategy for New Products Introduction, with a focus on the end-to-end process, and on the continuous improvement of the registration stages and times to be first in the market.
• Managing at regional level the life cycle stage for the product's portfolio (New indications, territory extensions, artworks,labeling/CMC changes, etc).
• Management of regional activities like submission strategy definition with local affiliates and other internal stakeholders (regional supply, marketing industrial and business units).
• Regional Renewal Plan Leader
• Regional Team management

• Regulatory management of innovation projects for the Andean cluster, aligned with the business growth objectives for Bayer LATAM.
• Execution and maintenance of the regulatory plan for: new registrations, renewals, OTC Switch, management and control of promotional and advertising material for the countries that make up the Andean region.
• Representation of Bayer before the different unions and associations of the ANDEAN countries: ANDI, ALAFARPE and IFI.
• Regional Team management

· Development, management and execution of the regulatory plan for Colombia for new submissions and approvals, in alignment with the business growth objectives and in compliance with the country's health regulations.

· Regulatory maintenance of the Abbott EPD portfolio in Colombia (Biosimilars, chemical synthesis products and OTC), responsible for the traceability of the activities carried out, guaranteeing the GMP standards and execution of the corporation's internal policies.

· Leading the LATAM portfolio expansion regulatory team (26 people) that supports the two local manufacturing plants.

• Definition and execution of the regulatory plan for Abbott Legacy products (Vaccines and Pharma) in the different Latin American affiliates.
• Management and implementation of the DARIUS project (Abbott EPD global system), as a regulatory traceability tool in the different Latin American affiliates.

• Active participation in the development of regulatory strategies for new registration projects in LATAM in coordination with affiliates in Latin America, product leaders and global projects, to fully comply with the execution of the submission and approval plan.
• Responsible for the RPL team at the LATAM level, located in Mexico, Chile and Colombia, which provide technical and CMC support to the different subsidiaries in the region.

• Provide CMC and legal support for obtaining health registrations belonging to the Abbott-EPD portfolio, in compliance with the global plan defined for Latin America.
• Participation in the development of regulatory strategies for new projects for the region in cooperation with the Global working groups.

• Coordination, preparation and submission of technical-legal information to obtain new health registrations for biological products, biosimilars and imported chemically synthesized products (immunosuppressants and kinase inhibitors) before INVIMA.
• Responsible for processing renewals and modifications of the company's imported products.
• Management of pharmacological procedures before the specialized medicines room of the INVIMA review committee.

• Execution and monitoring of regulatory activities related to obtaining and maintaining the company's health records (vaccines), complying with the annual prioritization of dossiers.